Benicar (olmesartan) is an angiotensin II receptor antagonist (ARA) drug manufactured by Daiichi-Sankyo. It reduces blood pressure by blocking the action of a hormone in the body that causes blood vessels to constrict. The U.S. Food and Drug Administration (FDA) approved Benicar for treatment of hypertension on April 5, 2002. Since the drug was released on the market, serious health concerns have developed concerning olmesartan, including cardiovascular risks in diabetics.
A number of severe side effects are associated with Benicar. If you or a loved one has suffered serious health consequences from taking this drug, speak with a knowledgeable product liability attorney as soon as possible. You may be entitled to hold the manufacturer accountable and recover compensation for the losses you have suffered. Our practice at Farah & Farah is dedicated to representing people harmed by dangerous drugs and devices. We are investigating cases nationwide involving injuries caused by Benicar.
FDA Review of Benicar and Heart Risks
After research revealed a higher risk of cardiovascular death for diabetics taking Benicar, FDA issued 3 Drug Safety Communications about this serious health concern:
- On June 11, 2010, the FDA launched an ongoing safety review of Benicar and cardiovascular events based on data from two clinical trials in which Type II diabetes patients on Benicar were found to have a higher risk of death from cardiovascular causes than patients taking placebos.
- On April 14, 2011, the FDA issued an update on the safety review. FDA determined that the benefits of Benicar for treatment of hypertension continued to outweigh the risks. It also stated that Daiichi-Sankyo and the FDA would work together to perform more studies and analyses of completed studies and update the public when new information became available.
- On June 24, 2014, the FDA announced that it had completed its safety review and found no clear evidence that taking Benicar increases cardiovascular risks for diabetics. FDA stated that the benefits of the drug for treatment of hypertension continue to outweigh the risks.
Research on Benicar and Heart Risks
The first clinical trial that prompted the FDA safety review of Benicar and cardiovascular events is titled The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study, published by the National Institutes of Health (NIH). The purpose of the study was to determine if olmesartan (Benicar) could impede the progression of kidney disease in diabetic patients.
Researchers evaluated 1,758 diabetic patients for an average of 3.3 years. Benicar was given to 881 patients and a placebo was given to 877. Researchers in this study observed that the patients taking Benicar had a higher risk of cardiovascular death.
The second clinical trial, The Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Neuropathy Trial (ORIENT), was a randomized, double-blind study conducted in Japan and Hong Kong to evaluate the effectiveness and safety of olmesartan on progression of renal disease in diabetics. Again, an unexpected result in this study was an increased number of cardiovascular deaths in the diabetic patients taking Benicar compared to the placebo group.
In the ROADMAP clinical trial, there were 15 cardiovascular deaths among the patients taking olmesartan and 2 in the placebo group. In the ORIENT clinical trial, there were 10 cardiovascular deaths in the olmesartan group and 3 in the placebo group. The evidence in both clinical trials combined was sufficient to cause FDA to launch a four-year safety review on the subject.
In its June 24, 2014 announcement, FDA stated that it had reviewed additional studies, including a large study of Medicare patients, which also suggested that a high dose of Benicar may increase cardiovascular risk for diabetics. Nevertheless, FDA determined that the data was not conclusive and ended its safety review.
In its conclusion, FDA stated that the results of the Medicare study seemed to support the finding in ROADMAP; however, discrepancies in the Medicare study raised concerns about its credibility. The discrepancy that concerned FDA was the large decrease in survival of diabetic patients taking olmesartan as compared to a large increase in survival of non-diabetic patients taking olmesartan.
While FDA may have no conclusive evidence that Benicar increases cardiovascular risk in diabetics, neither is there evidence that it does not.
Our tenacious drug injury attorneys at Farah & Farah represent clients who are seeking justice and compensation for injuries caused by dangerous drugs and devices. We believe that Big Pharma should be held accountable for the harm their products cause. If you have suffered serious side effects from Benicar, call us at (800) 533-3555 for a free case evaluation.